Information for researches

Introduction:

The National Cancer Research Centre Biobank (CNIO-Biobank) is established as a cross-service platform for CNIO researchers and the scientific community in general.

CNIO Biobank is, as defined by the Spanish Law 14/2007 on biomedical research, and Royal Decree RD 1716/2011, a “Biobank for biomedical research purposes”.

As such it is defined as a public, non-profit organisation which hosts several collections of human biological samples to be used for biomedical research; it is organised as a technical unit with strict criteria of quality, order and purpose, independently of hosting other collections of biological samples for different purposes.

Portfolio of services:

The Biobank legal Scheme:

Collection, management, manipulation and custody of human biological samples and associated documentation, all under the scope of the Biobank legal scheme.

Transfer of samples and clinical biomedical information to research projects, under the approval of the corresponding scientific and ethical committees.

Management of other collections

Custody service of collections of biological samples and / or information related to biomedical research promoted by CNIO or other external research groups.

Researchers who want to deposit their collections at CNIO-Biobank facilities or request samples must sign an MTA (Material Transfer Agreement) which specifies the terms and conditions under which the Biobank will custody samples and data.

Ethical-legal advice concerning the use of human samples in biomedical research

Technical, scientific and ethical advice regarding the collection, storage and management of human samples used for biomedical research as well as in the creation and management of new collections that are out of the scope of the Biobank; in accordance with the present Spanish legal framework.

Collaboration and advising in the design and interpretation of immunohistochemical studies.

Quality Management Programme.

Conditions and service portfolio

According to Spanish law, the CNIO Biobank is a non-profit institution. The costs charged are only for processing material and storage, as well as for general management. The biological sample as such is free of cost.

As a general rule, Biobank samples do not include infectious or contagious material. However, working with human samples involves potential risk; therefore, researchers must follow the strict recommendations given in the CNIO and Biobank biosecurity document. The Biobank is not responsible for the potential unknown infectivity or lack of sterility of the material supplied.

The principal investigator assumes full responsibility for the information and training of the team involved in the project regarding the dangers and safety procedures to be followed when handling human tissues.

The CNIO is not responsible for any damage arising from the transport or handling of the material once it has been sent.

All material of human origin is provided for the sole purpose of its use in a specific research project and must be subject to common ethical and legal frameworks. It is expressly forbidden to supply biological samples to third parties without the proper authorisation from the Biobank as well as the Centre.

Researchers are responsible for the proper preservation of the samples and maintenance of their traceability.

The researcher, as signed in the perceptive MTA, is asked to give credit to the source of the samples served by the CNIO Biobank in every potential publication produced with this material, and must therefore, send a copy of the publication to the Biobank. Annually, the researcher is obliged to send a report of the samples used to the Biobank.

The Biobank is committed to deliver the material according to the agreed conditions and within the time established, as well as to provide anonymous information about the origin of the sample (age, gender and accurate pathological diagnosis). Obtaining clinical information associated with the samples cannot be guaranteed by the Biobank; this depends on the degree of collaboration that is reached with the clinicians in charge of each case.

Applications for material are subject to oversight by our institution´s Ethics and Scientific Committees, thus, requests will require a summary of the research project justification including the type, number and amount of sample required.

Pursuant to the provisions of Law 14/2007 on Biomedical Research, the Biobank will assign the minimum amount of tissue that is required for the investigator to achieve the objectives proposed in the research project for which the samples are requested.

The terms of this assignment shall be stated in the corresponding “Material Transfer Agreement” (MTA).

NOTE: Any request, once complete (including the application form and project details) must be submitted for evaluation to both Ethical and Scientific Committees (in accordance with Royal Decree 1716/2011). The Biobank can only process requests that have been given a positive assessment by both committees.

Due to the nature of our Biobank, it is possible that many requests may have to be processed via external Biobanks. This could reflect an additional cost and delay in the entire process.

How to apply for CNIO-Biobank samples?

The Biobank is authorized by the health authorities of the Community of Madrid as regulated in RD1716/2011 and listed on the National Register of Biobanks with reference B.000848